Neuralink gets FDA approval for ‘in-human’ trials of its brain-computer interface

The Neuralink device is designed to be surgically implanted and, according to CEO Elon Musk, will eventually be marketed to the general public.

Elon Musk’s brain-computer interface (BCI) startup, Neuralink, reportedly received approval from the United States Food and Drug Administration (FDA) to conduct some form of “in-human” trials for its surgically implanted brain device.

Congratulations Neuralink team! https://t.co/AWZGf33UDr

— Elon Musk (@elonmusk) May 26, 2023

It’s unclear at this time what kind of trials the Neuralink tweet is referring to — the only other information mentioned was that the company isn’t accepting applicants yet.

Neuralink was denied the FDA’s approval for human trials in early 2022 over several concerns related to safety, which, at the time, the company was reportedly working to resolve.

The FDA’s apparent U-turn would indicate that such concerns have been worked out, and the company should then be free to conduct limited testing of its surgically implanted BCI device.

In describing the function of the BCI, Elon Musk has stated it would help with certain medical and mobility issues. BCIs are developed for the treatment of numerous conditions, such as epilepsy. They also provide quality-of-life services for disabled persons, such as the ability to direct a mouse cursor via eye movement or thought.

Musk has also said the device would be developed for use by the general public as a general-purpose BCI, which allows humans to interface with machines via thought and protect us from being replaced by machines.

Until now, Neuralink has only been allowed to conduct testing on laboratory animals such as monkeys and pigs. The company recently faced a federal probe over alleged animal mistreatment; however, Neuralink denied any wrongdoing, and the investigation appears to have ended quietly. A separate investigation over the alleged transportation of contaminated devices remains ongoing.

With human testing on the table, Musk’s vision for hybrids of humans and artificial intelligence (AI) comes one step closer. It therefore might be time for developers and entrepreneurs to start considering the applications and use cases of a recreational, surgically implanted BCI.

Musk has also proposed that BCIs would allow people to operate smartphones faster with their minds than they could with their thumbs. Recent research from the University of Texas has demonstrated that AI systems similar to ChatGPT can already be trained to interpret brain waves to a limited degree.

But perhaps the most interesting potential use case for the cryptocurrency and blockchain communities comes from Microsoft. Several patents filed in 2018 and 2019 describe a system by which a wearable “sensor” could be engineered to provide “proof-of-work” for cryptocurrency rewards and blockchain mining and validation.

According to one of the patent filings:

“For example, a brain wave or body heat emitted from the user when the user performs the task provided by an information or service provider, such as viewing advertisement or using certain internet services, can be used in the mining process.”

With a BCI like the one Neuralink describes in its original research paper and a paradigm like the one described in the Microsoft patent, it should be possible to validate brain waves natively, thus making it possible to verify “proof-of-work” via thought alone.